Mucositis
Conditions
Interventions
Experimental group A: Seventy individuals enrolled in the arm of Arrabidaea chica will receive tubes of an herbal gel containing 2.5% of the active standardized arrabidaea chica extract and will be in
Drug
Device
E02.594
Sponsors
Hospital de Clínicas da Universidade Estadual de Campinas
Fundação de Amparo à Pesquisa do estado de São Paulo
Faculdade de Ciências Farmacêuticas da Universidade Estadual de Campinas
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Men and women over 18 years old; squamous cell carcinoma of the head and neck; chemotherapy with cisplatin or carboplatin associated with radiotherapy; signs/symptoms of oral mucositis.
Exclusion criteria
Exclusion criteria: Tumor of a histological type other than carcinoma; nasopharyngeal tumor; ulcerative lesions; infections in the oral cavity before.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome will be mean duration of mucositis in days, measured by the mean and standard deviation of each group and association will be assessed by mean difference and 95% confidence interval. Mucositis will be measured by the Radiation Therapy Oncology Group scale to classify the effects of radiotherapy and the World Health Organization mucositis assessment scale. It is expected that there will be a reduction in the mean duration of oral mucositis in days. Oral mucositis from grade 2 or worse , measured through the mucositis scale of the World Health Organization, made pre intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome will include pain assessment, using a visual analogue scale (VAS) from 0 (no pain) to 10 (unbearable pain) and quality adjusted life years (QALY) by European Quality of Life 5-Dimensions (EQ-5D). Furthermore, a measurement of the diameter, in millimeters, of the oral lesion using a millimeter periodontal probe (Williams’s model) will be taken. Each patient will have their mouth photographed at enrolment and during intervention for documentation of the degree and extention of oral mucositis. Photographs will be read in ImageJ software. It is expected that there will be a reduction in the mean duration of oral mucositis in days. Pain assessment using a visual analogue scale (VAS) from 0 (no pain) to 10 (unbearable pain) and quality adjusted life years (QALY) by the European 5-Dimensional Quality of Life (EQ-5D); measurement of the diameter, in millimeters, of the oral lesion using a millimetric periodontal probe (Williams model), done before intervention. Photographic image of the mouth, pre and post intervention. | — |
Countries
Brazil
Contacts
Public ContactMary Ann Foglio
Faculdade de Ciências Farmacêuticas-Unicamp
Outcome results
None listed